Pivotal Assessment of the Effects of Bioactive on Health and Wellbeing. From Human Genome to Food Industry (PATHWAY-27)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Terminated

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: Bakery BEF; Dietary Supplement: Dairy placebo; Dietary Supplement: Bakery placebo; Dietary Supplement: Egg placebo; Dietary Supplement: Egg BEF; Dietary Supplement: Dairy BEF

Study type: Interventional

Funder types: Other

Identifiers

NCT02702713

147/2015/U/Sper

Details and patient eligibility

About

This is a multi-centre, randomised, double-blind, placebo-controlled, parallel-arm dietary intervention study. In total, 800 men and women at risk for Metabolic Syndrome (MS) will be recruited. Subjects will be eligible to the study if they present with two to four of the MS diagnostic criteria, at least one of them being:

• fasting triglycerides ≥150 mg/dL but ≤400 mg/dL OR
• HDL-cholesterol ≤50 mg/mL in women, ≤ 40mg/mL in men (with fasting triglycerides ≥110 mg/dL).

Each of the four recruiting centres will recruit 200 volunteers. Participants will be randomly assigned to one of four groups to receive either:

• Dairy BEF + egg placebo + bakery placebo
• Egg BEF + dairy placebo + bakery placebo
• Bakery BEF + dairy placebo + egg placebo
• Dairy, egg and bakery placebo

Participants will be required to consume all three of the allocated products each day for 12 weeks.

Eligible volunteers will be included and randomly allocated to one of the four groups. At baseline, 6 weeks and 12 weeks after inclusion, each participant will visit the recruiting centre for clinical and biochemical investigations. At 3 weeks and 9 weeks participants will complete questionnaires relating to their satisfaction with the food products, compliance to consumption of the study food products, and any gastrointestinal side effects or health-related adverse events that have occurred in the previous 3 weeks.

At each recruiting centre 40 participants will be required to take part in additional activities, these are: stool sample collection, adipose tissue aspiration, body composition analysis by dual energy x-ray absorptiometry (DEXA) and assessment of physical activity.

Enrollment: 325 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• subjects presenting with two to four diagnostic criteria for metabolic syndrome, at least one of them being elevated fasting triglycerides OR HDL-cholesterol ≤50 mg/mL in women, ≤ 40mg/mL in men (with fasting triglycerides ≥110 mg/dL).

Exclusion criteria

• subjects with five clinical criteria for metabolic syndrome
• Regular drug therapy with impact on serum lipids;
• Diabetes (fasting glucose > 1.26 g/L, or anti-diabetic treatment);
• Celiac disease, lactose intolerance, allergy to milk or egg proteins;
• Antibiotic treatment within the last 3 months;
• Recent history of cancer or cancer treatment (less than 2 years);
• Active or recently diagnosed intestinal malabsorption;
• Diagnosis of organ failure
• Familial dyslipidemia (TG ≥ 4.5 mmol/l or 400 mg/dl);
• Illegal drug use or chronic alcoholism or smoking;
• Intensive physical exercise (≥ 5 hour/week);
• Consumption of nutritional supplements containing DHA, BG or AC;
• History of allergy or intolerance to any components used in BEF;
• Women who are pregnant or lactating;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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325 participants in 4 patient groups, including a placebo group

Dairy BEF + egg placebo + bakery placebo

Active Comparator group

Description:

200 subjects consuming every day for 12 weeks: 1 portion of Dairy BEF + 1 portion of Egg placebo + 1 portion of Bakery placebo

Treatment:

Dietary Supplement: Egg placebo

Dietary Supplement: Bakery placebo

Dietary Supplement: Dairy BEF

Egg BEF + dairy placebo + bakery placebo

Active Comparator group

Description:

200 subjects consuming every day for 12 weeks: 1 portion of Egg BEF + 1 portion of Dairy placebo + 1 portion of Bakery placebo

Treatment:

Dietary Supplement: Dairy placebo

Dietary Supplement: Bakery placebo

Dietary Supplement: Egg BEF

Bakery BEF + dairy placebo + egg placebo

Active Comparator group

Description:

200 subjects consuming every day for 12 weeks: 1 portion of Bakery BEF + 1 portion of Dairy placebo + 1 portion of Egg placebo

Treatment:

Dietary Supplement: Egg placebo

Dietary Supplement: Bakery BEF

Dietary Supplement: Dairy placebo

All placebo

Placebo Comparator group

Description:

200 subjects consuming every day for 12 weeks: 1 portion of Egg placebo + 1 portion of Dairy placebo + 1 portion of Bakery placebo

Treatment:

Dietary Supplement: Egg placebo

Dietary Supplement: Dairy placebo

Dietary Supplement: Bakery placebo